FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
67091-138
11-digit product format
670910138
Labeler code
67091
Product ID
67091-138_289ba9d7-2845-5bdc-e063-6394a90af81c
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET, COATED
Route
ORAL
Labeler
WinCo Foods, LLC
Application
ANDA079096
Marketing category
ANDA
Marketing start
2014-12-15
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-138-50Naproxen Sodium1 in 1 CARTONTABLET, COATED13
67091-138-50Naproxen Sodium50 in 1 BOTTLE, PLASTICTABLET, COATED503

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-138NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]3Current NDC, Legacy NDC, 2 package rows20241208_44ef3ef4-9495-4a63-92f0-f0ab19c4ec23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN44ef3ef4-9495-4a63-92f0-f0ab19c4ec233
849574naproxen sodium 220 MG Oral TabletSCD44ef3ef4-9495-4a63-92f0-f0ab19c4ec233
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY44ef3ef4-9495-4a63-92f0-f0ab19c4ec233

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67091-138-50670910138501 BOTTLE, PLASTIC in 1 CARTON (67091-138-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2014-12-150000-00-00NoNoCurrent